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The Accu-Chek Mobile blood glucose monitoring system used under controlled conditions meets ISO 15197 standards in the hands of diabetes patients
Department of Medical Biochemistry, Oslo University Hospital, University of Oslo, Oslo, Norway.
Oslo University Hospital, University of Oslo, Oslo, Norway.
University and Regional Laboratories, Region Skåne, Kristianstad, Sweden.
Oslo University Hospital, University of Oslo, Oslo, Norway.
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2012 (English)In: Scandinavian Journal of Clinical and Laboratory Investigation, ISSN 0036-5513, E-ISSN 1502-7686, Vol. 72, no 5, p. 374-379Article in journal (Refereed) Published
Abstract [en]

Background. Self-monitoring of blood glucose is a cornerstone of diabetes management. The aim of this study was to evaluate the analytical quality and the ease of use of the Accu-Chek Mobile, a new glucose monitoring system designed for capillary blood testing by diabetic patients.

Materials and methods: The performance of the Accu-Chek Mobile was evaluated both in the hands of a scientist and of diabetes patients. The designated comparative method was a hexokinase-based laboratory method (Architect ci8200). Diabetics (N = 88) with previous experience of self-testing were recruited for the study. Patient samples, containing glucose in concentrations mainly between similar to 4 and similar to 20 mmol/L, were analyzed in duplicates both on the Accu-Chek Mobile and with the comparative method. The patients answered a questionnaire about the ease of use of the meter.

Results: The meter yields reproducible readings, with an imprecision CV <5% as required by the American Diabetes Association (ADA). Of the glucose concentrations obtained by both the scientist and the patients, more than 95% of the individual results were within +/- 20% of the comparative method, meeting the ISO 15197 accuracy goal, but not the stricter +/- 10% ADA goal.

Conclusion: Accu-Chek Mobile is a user-friendly glucometer that in a normo- and hyperglycemic range fulfils the ISO 15197 accuracy requirement, also in the hands of diabetes patients.

Place, publisher, year, edition, pages
London, United Kingdom: Informa Healthcare, 2012. Vol. 72, no 5, p. 374-379
Keywords [en]
Analytical quality, diabetes mellitus, plasma glucose, point-of-care, self-testing
National Category
Medical and Health Sciences Endocrinology and Diabetes
Research subject
Medicine
Identifiers
URN: urn:nbn:se:oru:diva-25961DOI: 10.3109/00365513.2012.677544ISI: 000307636100005PubMedID: 22900743Scopus ID: 2-s2.0-84865331969OAI: oai:DiVA.org:oru-25961DiVA, id: diva2:555803
Available from: 2012-09-21 Created: 2012-09-21 Last updated: 2019-03-29Bibliographically approved

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Isaksson, Helena S.

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School of Health and Medical Sciences, Örebro University, Sweden
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Medical and Health SciencesEndocrinology and Diabetes

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